Published Works | FDLI | 28 April 2022

Agencies Unbound: How COVID-19 Prompted Regulatory Flexibility and What it May Mean for the Future

The COVID-19 crisis called for governmental responses of unprecedented scale, scope, and speed. COVID-19 stressed not only medical infrastructure, supply chains, and financial systems, but also the very regulatory apparatus the government must use to react. Regulatory agencies had to respond nimbly, with at times imperfect information and in unfamiliar territory beyond their core mission areas. Agencies accustomed to following deliberate administrative processes had to act and make significant policy decisions in mere days, balancing important competing concerns, such as keeping critical infrastructure operating while curtailing virus transmission, requiring cross-agency partnership. And regulatory agencies found great value in collaboration with industry and other stakeholders.

Flexible regulatory approaches emerged by necessity to allow FDA and USDA to respond to the public’s need for access to food, personal protective equipment, and other critical items. Designated “critical infrastructure sectors,” key industries required decisive shifts in how these agencies traditionally go about the business of regulation to protect public welfare during the evolving pandemic. Viewing agency actions through the lens of the food industry, this Article analyzes the key regulatory strategies used by FDA and USDA (in conjunction with CDC and other agencies), identifies key learnings from how those strategies worked in the initial phase of the COVID-19 crisis, and explores ways for regulatory agencies to build on those processes, both for future crisis response and day-to-day regulatory activities.

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